This is a Phase 1/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors

Conditions: Colorectal Cancer, Advanced/Metastatic Solid Tumor, Solid Tumor (Phase I), EPCAM, Colon Cancer

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE1

Enrollment: 152

Sponsor: LTZ Therapeutics, Inc.

Summary

This is a first-in-human, Phase 1, multi-center, open-label study to characterize the safety, pharmacokinetics, pharmacodynamics, and preliminary anti tumor activity of LTZ-232 as monotherapy in adult participants with unresectable or metastatic colorectal cancer and other solid tumors failing standard therapies.

Eligibility Criteria

Inclusion Criteria: * Advanced /metastatic colorectal tumors that have failed standard treatments * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) * Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 * Adequate organ function based on laboratory testing Exclusion Criteria: * Active infection with hepatitis B or C * Uncontrolled CNS metastases * Active autoimmune disease * Clinically significant cardiovascular disease not adequately controlled with medication or impaired function * Previous treatment with EpCAM targeting agent * Pregnant or breast feeding * Non-colorectal active malignancy within 3 years that could interfere with study interpretation

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07878988). StuddyBuddy aggregates publicly available trial information.